An Open Randomized Controlled Clinical Trial to Evaluate the Efficacy of Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti in Prameha with special reference to Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- To find out the effect of Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti on HbA1c
研究概览
简要总结
The present study is an open randomized controlled clinical trial designed to evaluate the efficacy of Vidangadi Lauha alone and in combination with Vastyamayantaka Ghrita Matra Basti in Prameha (Type 2 Diabetes Mellitus). A total of 99 patients equally divided into three groups
Group A Metformin
Group B Metformin and Vidangadi Lauha
Group C Metformin and Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti
Each treatment will continue for 3 months, Basti will be given for 11 days in each month for 3 consecutive months, with follow-up at 0th, 30th, 60th, and 90th day. Assessment will be based on HbA1c, eGFR, lipid profile, microalbumin-creatinine ratio, and clinical symptoms. The study aims to assess changes in HbA1c, eGFR, and microalbumin-creatinine ratio to determine whether the Ayurvedic regimen offers superior glycemic and renal outcomes compared to Metformin alone.
Primary Hypothesis
Null Hypothesis H0 Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti are not more effective than Metformin in the management of Type 2 Diabetes Mellitus.
Alternate Hypothesis H1 Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti are more effective than Metformin in the management of Type 2 Diabetes Mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Fasting blood sugar more than 126 mg/dl and less than or equal to 250 mg/dl Postprandial blood sugar more than 140 mg/dl and less than or equal to 350 mg/dl HbA1c between 6.5 to 9.5 percentage Presence of 1 or more classical symptom of Prameha.
排除标准
- •Type 1 Diabetes Mellitus or Gestational Diabetes Patients on insulin or steroid therapy History of ketoacidosis, diabetic coma, or severe infections Major systemic illnesses Immunocompromised patients or those on immunosuppressants Severe hypertension i.e more than 180/100 mmHg.
结局指标
主要结局
To find out the effect of Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti on HbA1c
时间窗: Assessment on 0th 30th 60th 90th day.
To assess the symptomatic relief .
时间窗: Assessment on 0th 30th 60th 90th day.
次要结局
- To evaluate the efficacy of Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti on Diabetic Nephropathy parameters eGFR, microalbumin-creatinine ratio, serum electrolytes.(Assessment on 0th 30th 60th 90th day.)
研究者
Dr Tejas Modhale
Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College.